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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04167358
Registration number
NCT04167358
Ethics application status
Date submitted
15/11/2019
Date registered
18/11/2019
Date last updated
7/11/2023
Titles & IDs
Public title
Linerixibat Long-term Safety, and Tolerability Study
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Scientific title
Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis
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Secondary ID [1]
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2019-003158-10
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Secondary ID [2]
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212358
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Universal Trial Number (UTN)
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Trial acronym
LLSAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Oral and Gastrointestinal
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0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Linerixibat
Experimental: Participants receiving linerixibat - Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat.
Treatment: Drugs: Linerixibat
All participants will receive linerixibat.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
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Assessment method [1]
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AEs and SAEs will be collected.
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Timepoint [1]
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Up to 66 months
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Primary outcome [2]
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Number of participants with Severe AEs
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Assessment method [2]
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AEs and SAEs will be collected.
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Timepoint [2]
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Up to 66 months
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Secondary outcome [1]
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Change in domain scores of the PBC-40 over time
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Assessment method [1]
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The PBC-40 is a participant-derived, disease specific health-related quality of life (QoL) measure with data to support its validity in PBC. The PBC-40 measure is comprised of 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact) grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional).
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Timepoint [1]
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Baseline and up to 65 months
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Secondary outcome [2]
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Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only)
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Assessment method [2]
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The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems.
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Timepoint [2]
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Baseline and up to 65 months
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Secondary outcome [3]
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Change in self-rated health by EQ VAS scores over time (Group 1 only)
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Assessment method [3]
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The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ VAS records self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
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Timepoint [3]
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Baseline and up to 65 months
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Secondary outcome [4]
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Change in the Beck Depression Inventory (BDI-II) scores over time
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Assessment method [4]
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The BDI-II is a 21-item questionnaire used to assess the intensity of depression in clinical and normal participants. Each item is scored from 0 (Normal) to 3 (Severe). The total score on the BDI-II ranges from 0-63, with higher scores reflecting higher levels of depression.
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Timepoint [4]
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Baseline and up to 65 months
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Secondary outcome [5]
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Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters
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Assessment method [5]
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Blood samples will be collected for the analysis of hematology, biochemistry (including lipid and liver parameters) and coagulation parameters.
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Timepoint [5]
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Baseline and up to 65 months
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Secondary outcome [6]
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Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only)
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Assessment method [6]
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Monthly Itch Score (MIS) will be assessed using an numerical rating scale (NRS), ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Response thresholds of greater than or equal to (>=) 2, >=3, and >=4-point reduction in MIS will be assessed.
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Timepoint [6]
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Week 24 and Week 52 of continuous treatment
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Secondary outcome [7]
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Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only)
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Assessment method [7]
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The MIS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Maintenance of efficacy occurs when a participant is a responder (>=2, >=3, and >=4-point reduction in MIS) at Week 24 of continuous treatment and is also a responder at Week 52 of continuous treatment.
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Timepoint [7]
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Week 52 of continuous treatment
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Secondary outcome [8]
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Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)
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Assessment method [8]
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The MSS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. This will be assessed at Week 52 of continuous treatment.
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Timepoint [8]
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Baseline and up to Week 52 of continuous treatment
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Secondary outcome [9]
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Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)
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Assessment method [9]
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The MFS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no fatigue and 10 the worst possible fatigue. This will be assessed at Week 52 of continuous treatment.
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Timepoint [9]
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Baseline and up to Week 52 of continuous treatment
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Eligibility
Key inclusion criteria
- Male and female participants must be 18 to 80 years of age inclusive, at the time of
signing the informed consent in the participant's parent trial BAT117213, GLIMMER or
GLISTEN.
- Participants with a diagnosis of PBC and a history of associated pruritus as evidenced
by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER
or GLISTEN).
- Participants must have completed the main treatment period in a prior eligible
linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least one of the following conditions applies: a) is a woman of
non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP)
and using an acceptable contraceptive method.
- Capable of giving signed informed consent.
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Screening total bilirubin >2x upper limit of normal (ULN).
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
- Screening estimated glomerular filtration rate (eGFR) <30 milliliters per minute per
1.73 square meter (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) equation.
- Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
- Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B [HBV],
viral Hepatitis C [HCV]) infection), primary sclerosing cholangitis (PSC), alcoholic
liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
- Current clinically significant diarrhea in the Investigator's medical opinion.
- Current symptomatic cholelithiasis or cholecystitis.
- Current diagnosis or previous diagnosis of colorectal cancer.
- Any current malignancies (including hematologic and solid malignancies).
- History of bariatric surgery with ileal bypass at any time, or any bariatric surgery
performed in the past 3 years.
- Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and
may not restart until after the end of the study or early study withdrawal.
- Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1
month prior to screening until after the end of the study or early study withdrawal.
- QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
- Participants with moderate (or greater) alcohol consumption defined as more than one
standard drink per day for women and two drinks per day for men.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/02/2027
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Actual
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Sample size
Target
305
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04167358
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for public queries
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US GSK Clinical Trials Call Center
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Phone
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877-379-3718
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT04167358
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